MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00082537
First received: May 11, 2004
Last updated: September 16, 2014
Last verified: September 2014

May 11, 2004
September 16, 2014
April 2004
October 2006   (final data collection date for primary outcome measure)
To estimate the proportion of patients treated with caspofungin reporting one or more clinical and/or laboratory drug-related adverse experience(s) during the study drug therapy period plus 14 days posttherapy
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Complete list of historical versions of study NCT00082537 on ClinicalTrials.gov Archive Site
Proportion of patients with a favorable overall response
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MK0991 Versus Amphotericin B for Empirical Therapy in Febrile, Neutropenic Pediatric Patients (0991-044)
A Multicenter, Double-Blind, Randomized, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Versus (Amphotericin B) Liposome for Injection as Empirical Therapy in Pediatric Patients With Persistent Fever and Neutropenia

This study is a double-blind, randomized study of MK0991 versus liposomal amphotericin B in the empirical treatment of pediatric patients (ages 2 through 17 years) who have an absolute neutrophil count (ANC) below 500/microliter and who have fever despite broad antibiotic coverage. Such patients would be candidates for empirical therapy with an intravenous anti-fungal agent.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Neutropenia
  • Fever
  • Drug: caspofungin acetate
    Duration of Treatment: 28-90 days
    Other Name: MK0991
  • Drug: Comparator: AmBisome
    Duration of Treatment: 28-90 days
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Maertens JA, Madero L, Reilly AF, Lehrnbecher T, Groll AH, Jafri HS, Green M, Nania JJ, Bourque MR, Wise BA, Strohmaier KM, Taylor AF, Kartsonis NA, Chow JW, Arndt CA, DePauw BE, Walsh TJ; Caspofungin Pediatric Study Group. A randomized, double-blind, multicenter study of caspofungin versus liposomal amphotericin B for empiric antifungal therapy in pediatric patients with persistent fever and neutropenia. Pediatr Infect Dis J. 2010 May;29(5):415-20. doi: 10.1097/INF.0b013e3181da2171.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2006
October 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who are 2 through 17 years of age
  • Absolute Neutrophil Count (ANC) is below 500/microliter
  • Have persistent fever (at least 4 days) despite antibiotic therapy
Both
2 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00082537
0991-044, Formerly-0404ETPP, MK0991-044, 2004_101
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP